OncoMatch/Clinical Trials/NCT07480213
Adaptive Phase 1/2 Study of Dual-Target CAR-NK Cells in Relapsed/Refractory Small Cell Lung Cancer (SCLC)
Is NCT07480213 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including EB-DART-NK01 (DLL3/CD56 CAR-NK cells) and Lymphodepleting chemotherapy for small cell lung cancer (sclc).
Treatment: EB-DART-NK01 (DLL3/CD56 CAR-NK cells) · Lymphodepleting chemotherapy — This study is an open-label, multi-center, adaptive Phase 1/2 trial evaluating the safety, feasibility, and preliminary antitumor activity of allogeneic dual-target CAR-NK cell products in adults with relapsed or refractory small cell lung cancer (SCLC). Three candidate dual-target constructs (DLL3/CD56, DLL3/GD2, and CD56/GD2) will be assessed during dose escalation; a pre-specified interim assessment will select the most suitable construct to proceed into an expansion cohort at the recommended Phase 2 dose (RP2D).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: DLL3 any tested (testing required; no eligibility threshold specified)
Required: GD2 any tested (testing required; no eligibility threshold specified)
Required: NCAM1 any tested (testing required; no eligibility threshold specified)
Disease stage
Required: Stage IV
Metastatic disease required
metastatic, extensive-stage, or unresectable
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: platinum-based chemotherapy
relapsed or refractory after at least 1 prior systemic regimen (must include a platinum-based regimen unless contraindicated)
Cannot have received: gene-modified cellular therapy (CAR-T, CAR-NK)
Prior treatment with CAR-T, CAR-NK, or other gene-modified cellular therapy within 6 months
Cannot have received: therapy directed against investigational target antigens
Exception: if it would confound safety/efficacy assessment
any prior therapy directed against the investigational target antigens if it would confound safety/efficacy assessment
Cannot have received: allogeneic hematopoietic stem cell transplant
Allogeneic hematopoietic stem cell transplant within 6 months or active graft-versus-host disease
Lab requirements
Blood counts
ANC ≥ 1.0 x10^9/L, platelets ≥ 75 x10^9/L
Kidney function
creatinine clearance ≥ 50 mL/min
Liver function
AST/ALT ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN
Cardiac function
clinically significant cardiovascular disease excluded (e.g., recent MI within 6 months, uncontrolled arrhythmia, LVEF < 45%)
Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in the protocol (examples: ANC ≥ 1.0 x10^9/L, platelets ≥ 75 x10^9/L, creatinine clearance ≥ 50 mL/min, AST/ALT ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN). Clinically significant cardiovascular disease (e.g., recent myocardial infarction within 6 months, uncontrolled arrhythmia, LVEF < 45%) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07480213 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene-modified cellular therapy, therapy directed against investigational target antigens, allogeneic hematopoietic stem cell transplant disqualifies patients from enrollment.
Does this trial require DLL3?
Yes, DLL3 any tested is a required biomarker for enrollment.
Does this trial require GD2?
Yes, GD2 any tested is a required biomarker for enrollment.
Does this trial require NCAM1?
Yes, NCAM1 any tested is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages